Received Mar 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HIBV | HIB (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | UNK | IM / LL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 2 | UNK | PO / MO |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / RL |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 3 | UNK | IM / LL |
adenovirus infection; This 6-month-old male subject was enrolled in a blinded study. The subject received the 3rd dose of Bexsero vs Placebo (intramuscular, right thigh) on 29-NOV-2022, for prophylaxis. The subject received the 3rd dose of DTPa-HBV-IPV (intramuscular, left thigh) on 29-NOV-2022, for prophylaxis. The subject received the 3rd dose of Prevnar 13 (intramuscular, left thigh) on 29-NOV-2022, for prophylaxis. The subject received the 2nd dose of Rotarix lyophilized formulation (oral) on 06-OCT-2022, for prophylaxis. The subject received the 3rd dose of Hiberix (intramuscular, right thigh) on 29-NOV-2022, for prophylaxis. On 05-DEC-2022, 6 days after receiving Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13 and Hiberix and 60 days after receiving Rotarix lyophilized formulation, the subject developed moderate - grade 2 adenovirus infection (Verbatim: adenovirus infection). Serious criteria included hospitalization. The subject was treated with ondansetron (Zofran Disintegrating Tablet (Ondansetron)). The action taken with Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix was no change. The outcome of adenovirus infection was resolved on 21-DEC-2022. Diagnostic results (reference ranges are provided in parenthesis if available): Adenovirus test-In DEC-2022 Positive. The investigator considered that there was no reasonable possibility that the adenovirus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix. The company considered that there was no reasonable possibility that the adenovirus infection may have been caused by Bexsero vs Placebo, DTPa-HBV-IPV, Prevnar 13, Rotarix lyophilized formulation and Hiberix. GSK Receipt date: 16-DEC-2022 and 19-DEC-2022. patient was admitted to hospital with fever and dehydration on 06DEC2022. Discharged 06DEC2022 positive for adenovirus Follow-up information received on 24-JAN -2023. Summary of changes: Vaccination date updated, SAE term updated, TTO updated. Follow-up information received on 13-Feb-2023 Summary of Changes: Investigator Text and hospitalization details were updated. Follow-up information received on 13-Jul-2023. Summary of changes: Concomitant drug, event outcome date and outcome of event updated. Follow-up information received on 15-aug-2023. Summary of changes: Concomitant drug updated to treatment drug. Follow-up information received on 11-SEP-2023. Summary of changes: Narrative updated. Follow up information received on 11-Mar-2025. End of study Unblinding completed.; Sender's Comments: A case of Adenovirus infections, 6 days after receiving the 3rd dose of Bexsero vs Placebo, 3rd dose of DTPa-HBV-IPV, 3rd dose of Prevnar 13, 2nd dose of Rotarix lyophilized formulation , 3rd dose of Hiberix. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility.
Test Date: 202212; Test Name: Adenovirus test; Result Unstructured Data: (Test Result:Positive,Unit:unknown,Normal Low:,Normal High:)